120 Participants Needed

Diabetes Education App for Type 2 Diabetes

ME
PM
SS
Overseen BySally Snyder, MSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Reading Hospital and Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, participants in both study groups will continue their routine follow-up care with their primary care physicians, which suggests you may continue your current medications.

What data supports the effectiveness of the Diabetes Education App for Type 2 Diabetes treatment?

Research shows that using internet and technology-based tools for diabetes education can improve patient outcomes by providing personalized support and helping patients manage their condition more effectively. These tools allow patients to track their health data, receive timely feedback, and connect with healthcare providers and support networks, which can lead to better self-management and improved health outcomes.12345

Is the Diabetes Education App for Type 2 Diabetes safe for humans?

The available research does not provide specific safety data for the Diabetes Education App for Type 2 Diabetes, but similar apps have been tested for usability and feasibility, showing they are generally well-received and promote positive health behaviors.678910

How does the Diabetes Education App for Type 2 Diabetes differ from other treatments?

The Diabetes Education App for Type 2 Diabetes is unique because it provides an interactive and educational platform for self-management, using a mobile or web application to help users learn about and manage their condition effectively. Unlike traditional treatments that may focus solely on medication, this app emphasizes education and self-efficacy, offering tools like quizzes and a diabetes dictionary to enhance users' understanding and control of their diabetes.610111213

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study.Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study.Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled.Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.

Research Team

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Luis A Murillo, MD, MPH

Principal Investigator

Reading Hospital Tower Health

Eligibility Criteria

This trial is for adults over 18 with uncontrolled Type 2 Diabetes (HA1c >8.0) who are patients at the Family Healthcare Center, Reading Hospital Tower Health. It's not for pregnant individuals, incarcerated people, those without a smartphone, or anyone unable to consent.

Inclusion Criteria

Current patients of the Family Healthcare Center, Reading Hospital Tower health.
I have Type 2 Diabetes with an HA1c level above 8.0.

Exclusion Criteria

I am able to give my own consent to participate in the study.
Identified special populations (pregnancy or individuals currently incarcerated)
Patients without access to their own smart phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm use the diabetes education app for 6 months, while control arm participants continue routine care

6 months
Routine follow-up appointments with primary care physicians

Follow-up

Participants are monitored for changes in HA1C, blood pressure, BMI, and self-efficacy for diabetes management

6 months

Treatment Details

Interventions

  • Diabetes education web site application
Trial Overview The study tests a diabetes education app that provides videos on managing diabetes and lifestyle changes versus usual care without the app. The impact on blood sugar control (HA1C), body weight, blood pressure, and self-management confidence is measured.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Participants enrolled in the intervention arm will be given a 6-month access period to the diabetes education application designed by the study team. The web site will offer videos related to a specific areas of education concerning diabetes self-management. To encourage compliance, participant users will receive weekly notifications from the application that will guide them through viewing all videos in the series. Participants will continue routine follow-up appointments with their primary care physicians during the study period. There will be no restrictions on starting or stopping medications during the study period.
Group II: Control armActive Control1 Intervention
Participants in the control arm will not have access to the Diabetes Application. They will continue follow-up appointments according to the standard of care with their primary care physician, diabetic educators, etc. There are no restrictions on starting or stopping medications for patients within the control arm.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Reading Hospital and Medical Center

Lead Sponsor

Trials
14
Recruited
1,500+

Reading Hospital Foundation

Collaborator

Trials
1
Recruited
120+

Complete Statistical Services (Consult-Stat)

Collaborator

Trials
1
Recruited
120+

Findings from Research

A study evaluated 53 diabetes patient education websites out of 214 retrieved, revealing significant variability in the quality of information based on established educational criteria.
Improvements such as incorporating evidence-based medicine, emphasizing family support, and enhancing user feedback mechanisms could greatly enhance the effectiveness of these web-based resources for patient-centered diabetes care.
Evaluation of the quality and contents of diabetes mellitus patient education on Internet.Thakurdesai, PA., Kole, PL., Pareek, RP.[2019]
The Web-based POEM system significantly improved diabetes management in 274 patients with type-2 diabetes, leading to better control of fasting blood glucose, HbA1c, and total cholesterol levels compared to a control group.
Patients using the POEM system logged in an average of 8.5 times per month, indicating high engagement, which contributed to their improved clinical outcomes over the study period from September 2003 to May 2004.
Development and evaluation of a patient-oriented education system for diabetes management.Lee, TI., Yeh, YT., Liu, CT., et al.[2022]
E-health educational interventions for patients with type 1 diabetes (T1D) did not show a significant difference in HbA1c levels compared to standard care, based on a meta-analysis of 6 randomized controlled trials involving 757 subjects.
The study emphasizes the need for more rigorous and well-designed trials to explore how e-health education can be effectively integrated into clinical practice for better diabetes management.
E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.Feigerlovรก, E., Oussalah, A., Zuily, S., et al.[2022]

References

Evaluation of the quality and contents of diabetes mellitus patient education on Internet. [2019]
Development and evaluation of a patient-oriented education system for diabetes management. [2022]
E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. [2022]
A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. [2022]
Internet and information technology use in treatment of diabetes. [2022]
New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]
Adherence to evidence-based guidelines among diabetes self-management apps. [2021]
The Development of a Diabetes Application for Patients With Poorly Controlled Type 2 Diabetes Mellitus. [2019]
Computer-based remote diabetes education for school personnel. [2006]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Six-month Outcomes of Mobile Phone Application-based Self-management in a Patient with Type 2 Diabetes. [2020]
Interactive educational diabetes simulators: future possibilities. [2011]
12.United Statespubmed.ncbi.nlm.nih.gov
Interactive Multimedia Tailored to Improve Diabetes Self-Management. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
The freeware AIDA interactive educational diabetes simulator--http://www.2aida.org--(2). Simulating glycosylated haemoglobin (HbA1c) levels in AIDA v4.3. [2007]
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